FDA 510(k)

FLIX-EMS

K-Number: K181419 · 2019-05-14

Decision Date2019-05-14

Product CodeNGX

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

FLIX-EMS is the device name listed in this FDA 510(k) record. The listed applicant is Casgarum Investment, S.L.. It received FDA 510(k) clearance on 2019-05-14 under 510(k) number K181419. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLIX-EMS?

FLIX-EMS is a medical device that received FDA 510(k) clearance on 2019-05-14. The listed applicant is Casgarum Investment, S.L.. The 510(k) number is K181419.

When did FLIX-EMS receive FDA 510(k) clearance?

FLIX-EMS received FDA 510(k) clearance on 2019-05-14, under 510(k) number K181419.

Who is the listed applicant for FLIX-EMS?

The FDA 510(k) record lists Casgarum Investment, S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLIX-EMS?

The FDA product code for FLIX-EMS is NGX.

Related Devices (Code: NGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology Limited K253926DiacoreShenB Co., Ltd.K253636Zionic Pro Max (EMS)Termosalud S.L.K253408CoolToneZimmer Medizinsysteme GmbH K252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.